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EGFR Mutant Advanced Non-small Cell Lung CancerNCT07143045

A Prospective Cohort Study of Zorifertinib as a First-line Treatment in Patients With Epidermal Growth Factor Receptor-mutant Advanced Non-small Cell Lung Cancer With Central Nervous System (CNS) Metastases

An observational study of EGFR Mutant Advanced Non-small Cell Lung Cancer and Central Nervous System (CNS) Metastases, run by Alpha Biopharma (Jiangsu) Co., Ltd. at 34 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a patient-centered, two-group, three-cohort, multi-center, prospective study to further evaluate the survival benefits and safety of zorifertinib as a first-line treatment in EGFRm+ advanced NSCLC patients with CNS metastases, and to compare the clinical value of zorifertinib with other epidermal growth… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
zorifertinib
How many people
800 participants
Where
34 sitesChina
Study dates
29 Dec 2025to Nov 2031
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with advanced non-small cell lung cancer (NSCLC) who have been diagnosed with epidermal growth factor receptor mutation type (EGFRm+) and have central nervous system (CNS) metastasis

Who may be able to join

  • Male or female, aged ≥18 years.
  • Histologically or cytologically confirmed NSCLC with EGFR sensitizing mutations (including L858R or Exon 19Del), ineligible for curative surgery or radiotherapy.
  • CNS metastases diagnosed as brain metastases (BM) and/or leptomeningeal metastases (LM) by imaging and/or cerebrospinal fluid pathological examination.
  • Planning to receive zorifertinib (zorifertinib group) or other anti-tumor treatments (other treatment group) as first-line treatment.
  • Voluntarily agreeing to participate in this study and signing the informed consent form.
  • . No prior treatment with chemotherapy, EGFR-TKIs, biological therapy, immunotherapy, or any investigational drug that is considered first line treatment for advanced NSCLC.
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  • . Eligible patients are not candidates for definitive surgical resection or radiation of all lesions in the opinion of the treating physician.
  • . All patients must be stable without any systemic (oral or parenteral) corticosteroid or anticonvulsant therapy for at least 2 weeks prior to study treatment. Inhaled non-absorbable and topical corticosteroid use are permitted as indicated.
  • . Patients may have prior placement of a properly functioning CNS shunt or Ommaya reservoir.
  • . ECOG performance status 0 or 1, with no deterioration over the past 2 weeks, and expected survival time ≥ 3 months.
  • . Women of child-bearing potential (WOCBP) and male patients should agree to take medically acceptable contraception measures while on study treatment and for 3 months following completion of study treatment. All WOCBP must have a negative pregnancy test at screening.
  • . Patients with measurable CNS lesions must have at least one site of CNS lesion, which has not been previously irradiated, can be accurately measured at baseline as ≥ 10 mm in the longest diameter by MRI, and is suitable for accurate repeated measurements. Measurable extracranial lesions are not required. Patients with non-measurable CNS lesions must have at least one extracranial lesion, which has not been previously irradiated, can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except for lymph nodes which must have a short diameter ≥ 15 mm) by CT/MRI, and is suitable for accurate repeated measurements.

Who cannot join

  • Currently participating or planning to participate in any interventional clinical study for first-line treatment (patients who have participated in non-interventional, real-world studies may still be included).
  • Other reasons that, in the Investigator's opinion, make the patient unsuitable for this study.
  • For patients in Cohort A of the zorifertinib group, the following inclusion/exclusion criteria of the EVEREST study must also be met:
  • . Prior treatment with EGFR-TKIs (if EGFR-TKIs were used as adjuvant therapy, patients may be enrolled if the time from discontinuation to relapse meets the following requirements: >6 months for Cohort A, and >3 months for Cohorts B and C).
  • . Positive for T790M mutation documented by central or local laboratory using an approved or validated test method, or documented positive KRAS or cMET.
  • . Patients who have received any investigational drug, biological therapy, or immunotherapy for their malignant tumors within the past 21 days.
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  • . Patients who have had a major surgical procedure (excluding the need for placement of vascular access or a CNS shunt), or significant traumatic injury within 4 weeks of the first dose of study treatment, or have an anticipated need for major surgery during the study.
  • . Presence of only leptomeningeal metastases (LM) disease confirmed by MRI and/or positive cerebrospinal fluid (CSF) pathology, with no brain metastases (BM).
  • . Prior radiation therapy for CNS metastases that involves measurable or non-measurable sites of disease to assess efficacy.
  • . Patients who have received radiation to more than 30% of the bone marrow within 2 weeks before the first dose of study treatment.
  • . Patients currently receiving (or unable to stop use at least 1 week prior to receiving the first dose of study treatment) certain medications or herbal supplements that are known to be potent inhibitors or inducers of CYP3A4/5 (see Appendix A).
  • . Unmanageable nausea and vomiting, chronic gastrointestinal diseases, or prior gastric resection or surgical procedure that may interfere with adequate absorption of study drug.
  • . History of concurrent and/or other active malignant tumors requiring treatment within 5 years of study treatment, excluding prior treated squamous cell carcinoma or basal cell carcinoma or carcinoma in situ.
  • . History of any type of documented interstitial lung disease or radiation pneumonitis.
  • . Presence of any severe or uncontrolled systemic disease or condition, including: (i) uncontrolled hypertension or diabetes; (ii) serious cardiac, pulmonary or renal disorders; (iii) active bleeding diatheses; (iv) any active type of bacterial, viral, fungal or other infection that would pose a significant risk to the patient in the opinion of the Investigator; or (v) active hepatitis B virus positive (defined as hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) positive, and hepatitis B DNA positive (or detectable) or above the cut-off value) or positive HCV antibodies or positive HIV test result.
  • . Women who are pregnant or lactating. WOCBP and fertile men with a WOCBP-partner not using adequate contraception measures.
  • . Patients with unstable and symptomatic metastases: Any unstable and symptomatic CNS or distant metastasis that is not symptomatically controlled by prior surgery, radiotherapy or corticosteroid therapy within 2 weeks of initial study treatment.
  • . Any unresolved toxicities from prior therapy, greater than Common Terminology Criteria for Adverse Events (CTCAE 5.0) Grade 1 at the time of starting study treatment, with exception of alopecia.
  • . Patients with a significant cardiovascular disorder or condition, including any of the following:
  • Congestive heart failure (CHF) currently requiring treatment and patients with New York Heart Association (NYHA) Class III/IV CHF (see Appendix B).
  • Need for antiarrhythmic drug therapy for a ventricular arrhythmia or patients with uncontrolled or unstable arrhythmias.
  • Severe conduction disturbance (e.g., second- or third-degree AV block).
  • Angina pectoris requiring treatment.
  • QTc interval > 450 msec (males) or > 470 msec (females).
  • History of congenital long QT syndrome, congenital short QT syndrome, Torsades de Pointes, or Wolff Parkinson White syndrome.
  • Left ventricular ejection fraction (LVEF) <50% as determined by echocardiography or MUGA scan.
  • Myocardial infarction diagnosed within the past 6 months.
  • . Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
  • Absolute neutrophil count <1.5 × 109/L.
  • Platelet count <100 × 109/L (Transfusion-dependent patients are excluded from this study).
  • Hemoglobin <90 g/L.
  • Alanine aminotransferase (ALT) > 2.5 times the upper limit of normal (ULN) in the absence of documented metastases to liver or > 5 times the ULN in the presence of metastases to liver.
  • Aspartate aminotransferase (AST) > 2.5 times the ULN in the absence of documented metastases to liver or > 5 times the ULN in the presence of metastases to liver.
  • Total bilirubin > 1.5 times the ULN in the absence of metastases to liver or >3 times the ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or metastases to liver.
  • Creatinine >1.5 times the ULN concurrent with creatinine clearance <50 mL/min (measured or calculated by Cockcroft-Gault equation). Confirmation of creatinine clearance is only required when creatinine is >1.5 times the ULN.
  • If bone metastases are present and liver function is otherwise considered adequate by the Investigator, then isolated elevated alkaline phosphatase (ALP) is not an exclusion criterion.
  • . History of hypersensitivity to active or inactive excipients of the study drug or drugs with a similar chemical structure or class to the study drug.
  • . Judgment by the Investigator that the patient should not participate in the study if the patient is unwilling to comply with all study procedures and treatment.
  • . History of recent stroke (<6 months), or prior central nervous system injury that has persistent neurologic deficits that would affect neurologic assessments.
  • . Significant medical or psychiatric illness that would interfere with the compliance to the protocol and ability to tolerate treatment.
  • . Patients who have received any anti-neoplastic herbal medicines for their malignant tumors within the past 2 weeks.

Trial locations and contacts

34 sites in 1 country. Contact the study team or a site near you to ask about taking part.

John Ge M.D. contact

+86 (0)21-63862197

john.ge@alphabiopharma.com.cn

34 sites in 1 country

China34 sites, 34 recruiting

  • Beijing Tumor Hospital

    Beijing, Beijing Municipality, 100000

    Jun Zhao Professor, 13521469355, ohjerry@163.com

    Not yet recruiting

  • Capital Medical University Affiliated Beijing Chest Hospital

    Beijing, Beijing Municipality, 100000

    Hua Zheng Professor, 13520594655, zhenghua022@sina.com

    Recruiting

  • First Hospital of Jilin University

    Changchun, Jilin, 130000

    Xiao Chen Professor, 13596058596, chenxiao163@163.com

    Not yet recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410000

    Yongchang Zhang Professor, 13873123436, zhangyongchang@hnca.org.cn

    Not yet recruiting

  • Xiangya Hospital, Central South University

    Changsha, Hunan, 41000

    Bin Li Associate Professor, 13467713587, bincsuxy@csu.edu.cn

    Not yet recruiting

  • Chengdu Third People's Hospital

    Chengdu, Sichuan, 610000

    Yi Yang Associate Professor, 13980013944, syyxwkyy@163.com

    Not yet recruiting

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610000

    Juan Li Professor, 13880276636, dr.lijuan@hotmail.com

    Not yet recruiting

  • Chongqing University Affiliated Cancer Hospital

    Chongqing, Chongqing Municipality, 404100

    Ying Wang Professor, 13996412826, wy_cqszlyy@126.com

    Not yet recruiting

  • People's Liberation Army Army Specialized Medical Center

    Chongqing, Chongqing Municipality, 404100

    Mengxia Li Professor, 18580408265, mengxia.li@outlook.com

    Not yet recruiting

  • Dalian University of Technology Affiliated Central Hospital (Dalian Central Hospital)

    Dalian, Shandong, 116000

    Xiaomin Yu Professor, 15541190052, yuxiaomin201309@163.com

    Not yet recruiting

  • Foshan First People's Hospital

    Foshan, Guangdong, 510000

    Jun Jiang Professor, 18038865018, 2290836829@qq.com

    Weiquan Gu Professor, 18038865071, gwquan@fsyyy.com

    Recruiting

  • Heyou Hospital, Shunde District, Foshan City

    Foshan, Guangdong, 528000

    Shijun Kang Professor, 18680488453, 1733625900@qq.com

    Not yet recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350000

    Haipeng Xu Associate Professor, 13675007687, penghaixu@163.com

    Not yet recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510000

    Qing Zhou Professor, 13544561166, zhouqing@gdph.org.cn

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

    Baogang Liu Professor, 13804552752, baogangliu1962@163.com

    Not yet recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230000

    Yingying Du Associate Professor, 13956012561, duyingying@126.com

    Not yet recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650000

    Runxiang Yang Professor, 13888876721, yrx_research@163.com

    Not yet recruiting

  • Yunnan Provincial First People's Hospital

    Kunming, Yunnan, 650000

    Kun Miao Associate Professor, 18787156227, 22904816@qq.com

    Not yet recruiting

  • Meizhou People's Hospital

    Meizhou, Guangdong, 510000

    Guowu Wu Professor, 13823801920, wwwflay@126.com

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

    Jianjun Tang Associate Professor, 18079170486, tangjianjun204@163.com

    Not yet recruiting

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu, 210000

    Wen Gao Professor, 13951619963, Yoghurt831030@126.com

    Not yet recruiting

  • Nanjing Chest Hospital

    Nanjing, Jiangsu, 210000

    Yu Zhang Professor, 13912923279, 811284009@qq.com

    Not yet recruiting

  • Affiliated Cancer Hospital of Guangxi Medical University

    Nanning, Guangxi, 530000

    Qitao Yu Professor, 13878106696, yuqitaoac@126.com

    Liping Tan Associate Professor, 18776404799, 988tan@163.com

    Not yet recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530000

    Qing Bu Professor, 18277133566, buqing1993@qq.com

    Not yet recruiting

  • Qingdao University Affiliated Hospital

    Qingdao, Shandong, 266000

    Helei Hou Associate Professor, 18661800309, houheleiqdmh@163.com

    Not yet recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110000

    Mingfang Zhao Professor, 13644055129, zhaomf618@126.com

    Not yet recruiting

  • Shenzhen Hospital, Cancer Hospital, Chinese Academy of Medical Sciences

    Shenzhen, Shenzhen, 518000

    Jianhua Chang Professor, 18038168872, changjianhua@163.com

    Not yet recruiting

  • Shenzhen Third People's Hospital

    Shenzhen, Shenzhen, 518000

    Kun Qiao Professor, 13689565698, szqiaokun@163.com

    Not yet recruiting

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030000

    Junping Zhang Professor, 13994204099, junpingzhang@yeah.net

    Not yet recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 30000

    Peng Chen Professor, 18622221220, chenpengdoc@sina.com

    Not yet recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

    Xiaorong Dong Professor, 13986252286, xhzzdxr@126.com

    Not yet recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 350000

    Jingxun Wu Professor, 15160085395, jingxun_wu@163.com

    Not yet recruiting

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225000

    Buhai Wang Professor, 13813194298, Wbhself@sina.com

    Not yet recruiting

  • Henan Cancer Hospital

    Zhenzhou, Henan, 450000

    Huijuan Wang Professor, 18638561588, 18638561588@163.com

    Not yet recruiting

Other trials in China

About this study

This study is a patient-centered, two-group, three-cohort, multi-center, prospective study to further evaluate the survival benefits and safety of zorifertinib as a first-line treatment in EGFRm+ advanced NSCLC patients with CNS metastases, and to compare the clinical value of zorifertinib with other epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs).

Being tested
zorifertinib
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • zorifertinibDrug

    Cohort A and B will receive zorifertinib as first line treatment

Study groups in NCT07143045
Study groupRoleWhat they receive
Cohort APatients who receive first-line zorifertinib and meet the inclusion/exclusion criteria of the EVEREST study (the EVEREST study is a randomized, open-label, multi-center, Phase II/III study to compare the efficacy and safety of first-line zorifertinib versus gefitinib/erlotinib in EGFR-mutant advanced NSCLC patients with CNS metastases)
Receives: Drug: zorifertinib
Cohort BPatients who receive first-line zorifertinib but do not meet the inclusion/exclusion criteria of the EVEREST study (the EVEREST study is a randomized, open-label, multi-center, Phase II/III study to compare the efficacy and safety of first-line zorifertinib versus gefitinib/erlotinib in EGFR-mutant advanced NSCLC patients with CNS metastases)
Receives: Drug: zorifertinib
Cohort CPatients who receive various other anti-tumor drugs selected by the clinician, excluding zorifertinib, as first-line treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    The period from the first administration date of the study treatment to the date of death due to any cause.

    Measured: up to 36 months

Secondary outcomes (5)

  1. Incidence of Adverse Events (AEs) for zorifertinib

    All adverse events were classified according to the CTCAE (version: 5.0)

    Measured: up to 36 months

  2. Incidence of Dose Adjustments for zorifertinib

    The dose adjustments during the treatment by zorifertinib

    Measured: up to 36 months

  3. Progression-free survival (PFS)

    Investigator conducted the assessment based on RECIST 1.1

    Measured: every 8 weeks,up to 36 months

  4. intracranial Progression-free survival (iPFS)

    Investigator conducted the assessment based on RECIST 1.1

    Measured: every 8 weeks,up to 36 months

  5. Objective Response Rate (ORR)

    Investigator conducted the assessment based on RECIST 1.1

    Measured: every 8 weeks, up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2025
  2. Study start29 Dec 2025
  3. Primary completionMay 2031 (estimated)
  4. Study completionNov 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07143045
Sponsor's protocol ID
AZD3759-CIT-401
Status last verified
Feb 2026
First submitted
6 Aug 2025
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of EGFR Mutant Advanced Non-small Cell Lung Cancer and Central Nervous System (CNS) Metastases, run by Alpha Biopharma (Jiangsu) Co., Ltd. at 34 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact John Ge M.D. (+86 (0)21-63862197, john.ge@alphabiopharma.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: up to 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07143045.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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